Oral fluid collection device and method

Abstract

An oral fluid sampling method and apparatus includes a shield having a first side and a second side, an elastomeric nipple having an outer surface and defining a nipple interior extending from the first side of the shield, and a reservoir component extending from the second side of the shield with a reservoir having a reservoir interior, These elements are interconnected by a plurality of fluid conduit / valve combinations including a first combination that allows flow from the nipple interior to an atmospheric vent port disposed on the outer surface of the oral fluid sampling device, a second combination that allows flow from the reservoir interior to the nipple interior, and a third combination that allows flow from a collection port disposed on the outer surface of the nipple to an outlet port in the reservoir interior.

Description

[Technical Field]

[0001] The present invention relates to devices and methods for obtaining oral fluid samples from human subjects, and more particularly to devices, kits and methods for obtaining saliva samples from subjects, including infants and premature infants. [Background technology]

[0002] Analyte testing of human body fluids is routinely used to aid in the diagnosis of various disease states. Testing of blood, urine, and saliva is fairly common. Testing requires the collection of the body fluid, after which analysis is performed either at the collection site or, more commonly, at an approved laboratory.

[0003] Due to convenience and cost, among other advantages, there is an incentive to replace invasive blood tests with non-invasive saliva tests where possible. Blood tests require invasive blood collection, such as with a syringe. A trained person, such as a nurse or phlebotomist, must typically be present when the blood is collected. This adds both complexity and expense to the testing procedure when compared to the non-invasive collection of saliva.

[0004] Additionally, a significant proportion of the population experiences a pronounced aversion to needles. Infants, children, and some elderly people often abhor the use of needles.

[0005] Despite advances in using saliva to diagnose many conditions that previously required a blood sample, devices designed to collect saliva samples from adults may not be usable for pediatric and neonatal patients, who have small mouths and are unable to follow instructions. Additionally, significant safety concerns arise because the collector must be constructed to avoid the possibility of it becoming dislodged in the mouth and creating a choking hazard. Additionally, all components must be designed to prevent injury to the oral cavity. Summary of the Invention [Problem to be solved by the invention]

[0006] In summary, non-invasive collection of saliva for analyte testing has advantages over complex and costly invasive blood collection. There is a need for a saliva sample collection device that is safe to use and meets the special needs of pediatric and neonatal patients in particular. [Means for solving the problem]

[0007] The inventors have devised a safe-to-use oral fluid sampling device that meets the special needs of pediatric and neonatal patients in particular. The device includes a shield having a first side and a second side. The device includes an elastomeric nipple having an outer surface and defining a nipple interior extending from the first side of the shield, and a reservoir component extending from the second side of the shield, the reservoir component comprising a reservoir having a reservoir interior. These elements are interconnected by a plurality of fluid conduit / valve combinations, including a first fluid conduit having a first one-way valve operably connecting and enabling flow from the nipple interior to an atmospheric vent port disposed on the exterior surface of the oral fluid collection device, a second fluid conduit having a second one-way valve operably connecting and enabling flow from the reservoir interior to the nipple interior, and a third fluid conduit having a third one-way valve operably connecting and enabling flow from a collection port disposed on the outer surface of the nipple to an outlet port within the reservoir interior.

[0008] The method for collecting oral fluids is as follows: (a) removing the oral fluid collection device described above from its packaging; (b) inserting a nipple having an initial resting volume into the oral cavity of the subject; (c) deforming the nipple to force fluid from inside the nipple to an atmospheric vent port; (d) expanding the nipple toward the initial rest volume, thereby drawing fluid from within the reservoir and reducing fluid pressure within the reservoir component; (e) drawing oral fluid from the subject's oral cavity into the reservoir through the collection port.

[0009] Additional devices, kits, and methods are also disclosed. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a top front perspective view of an oral fluid collection device of the present invention. [Figure 2] 2 is a top rear perspective view of the oral fluid collection device of FIG. 1. FIG. [Figure 3] FIG. 2 is a side view of the oral fluid collection device of FIG. 1. [Figure 4] 2 is an exploded top front perspective view of the oral fluid collection device of FIG. 1. FIG. [Figure 5] 2 is an exploded top rear perspective view of the oral fluid collection device of FIG. 1. FIG. [Figure 6] 2 is a partial cross-sectional side view of the oral fluid collection device of FIG. 1. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0011] As used in this specification and claims, the term "oral fluid" and variations thereof refer to the fluids present in the oral cavity. Oral fluid is a mixture of saliva and "oral transudate." Saliva is produced by the salivary glands. Oral transudate enters the mouth by passing from capillaries through the buccal mucosa.

[0012] As used in this specification and claims, the term "collected fluid" and variations thereof refer to oral fluids (liquids) collected by the device.

[0013] As used in this specification and claims, the term "elastomeric nipple" and variations thereof refer to a device nipple that has a defined shape and has the ability to deform under load and return to its defined shape when the load is removed.

[0014] As used in this specification and claims, the term "exterior surface of the device" refers to any outwardly facing surface of the device in use when the elastomeric nipple is disposed within the oral cavity of a subject.

[0015] The present invention relates to a device and method for obtaining oral fluid samples from human subjects, particularly infants. The device is designed to use the subject's non-nutritive sucking movements to create a partial vacuum within the device that draws oral care fluid from the subject's oral cavity into a reservoir within the device.

[0016] The device includes a shield, an elastomeric nipple extending from a first side of the shield, and a reservoir portion extending from the other side of the shield. Both the nipple and reservoir have respective interiors and define respective volumes. The device also includes three fluid conduits, each with an associated one-way valve. A first conduit / valve combination allows airflow from the interior of the nipple to an atmospheric vent port disposed on the exterior surface of the device. A second conduit / valve combination allows airflow from the reservoir of the device to the interior of the nipple. A third conduit / valve combination allows oral fluid flow from a collection port located on the exterior surface of the nipple (which is disposed in the subject's oral cavity during use) to the reservoir and to an outlet port disposed within the reservoir.

[0017] The shield is positioned and configured to prevent the subject from attempting to place the entire device in their mouth, and thus functions to define the portion of the device that may be placed in the subject's mouth from the portion of the device that remains outside the mouth during use.

[0018] Similar to a conventional pacifier, the shield has a primary planar orientation that is disposed substantially parallel to the subject's lips when in use. The shield optionally includes a plurality of ventilation holes through its thickness that may allow air to pass through when the subject breathes through their mouth, or to provide other aesthetic or functional benefits.

[0019] The material used in making the shield is not critical and may include conventional pacifier shield materials such as non-toxic plastic materials, such as, but not limited to, polyethylene terephthalate (PET), high density polyethylene (HDPE), low density polyethylene (LDPE), or polypropylene (PP).

[0020] The shield may be formed by any useful plastic forming process, including but not limited to injection molding, thermoforming, and the like.

[0021] The elastomeric nipple extends from one side of the shield in a direction substantially perpendicular to the primary planar orientation of the shield. The elastomeric nipple has an outer nipple surface and an aperture formed in the outer nipple surface. As described above, the elastomeric nipple also defines a nipple interior. The nipple interior is hollow and is a void capable of receiving a fluid.

[0022] The material used in making the elastomeric nipple is not critical and may include conventional pacifier elastomeric nipple materials, such as non-toxic elastomeric materials. However, it is desirable to control the stiffness of elastomeric nipples produced from elastomers to allow the nipple to deform, as described in more detail below. Exemplary elastomeric materials include, but are not limited to, rubber (natural or latex), silicone, or soft plastic. Rubber, silicone, and soft plastic are easily deformable and, therefore, are effective when the elastomeric nipple is deformed by non-nutritive sucking movements (NNS) when in the subject's mouth. During non-nutritive sucking, the subject's tongue generally moves in a characteristic peristaltic motion (e.g., a wave-like motion from left to right).

[0023] The elastomeric nipple may be molded by any useful plastic molding process, including but not limited to injection molding, thermoforming, liquid silicone injection molding, and the like.

[0024] It may be desirable to select the same material for both the shield and nipple. This can be useful for integrating these components and eliminating a secondary connection between the two parts that could otherwise be a point of failure. In such a construction, the material for both the shield and nipple can be silicone or a soft plastic, including, but not limited to, a thermoplastic elastomer, or low durometer polyurethane.

[0025] The elastomeric nipple can be connected to the shield by a number of methods, which can vary depending on the materials used for the two elements. Useful methods include, but are not limited to, mechanical interference fit, fasteners / clamps, and bonding (e.g., adhesives, solvents, and / or heat, including ultrasonics). Of course, if the elastomeric nipple and shield are made of the same material, they can be molded together in a single operation. Alternatively, the shield and elastomeric nipple can be injection molded onto the stiffening element to provide the appropriate stiffness for the shield.

[0026] The reservoir is associated with the second surface of the shield and is disposed outside the subject's mouth during use. As described above, the reservoir defines a reservoir interior, i.e., a fluid-receiving void, within which oral fluids, such as saliva, collected by the device are stored.

[0027] The reservoir may also have at least one deformable zone, which may be one or more walls or portions thereof. The reservoir interior under ambient conditions defines an initial reservoir interior in which the at least one deformable zone is in a quiescent state. As described below with respect to the operation of the device, the at least one deformable zone can reduce the reservoir volume below the initial volume when certain operating conditions exist and return the reservoir volume to its quiescent state upon the return of normal operating conditions.

[0028] The reservoir may also contain a non-toxic stabilizing buffer solution, which allows the collected fluid for analysis to be preserved for days or even weeks after collection. The buffer solution may be disposed within the reservoir or added to the reservoir.

[0029] Because oral fluids such as saliva contain proteins and other biological substances that can adhere to the interior walls of the reservoir, these interior walls may be coated with a substance that prevents these proteins and other biological substances from adhering to them.

[0030] To be tested, the oral fluid collected by the device must be transported from the device to a testing facility. The testing facility may be part of a home testing system or may be located in a remote location. Therefore, the test fluid must be extracted from the device. This can be done by removing the reservoir from the device and transporting it to the testing facility, especially if the testing facility is located in a remote location. One convenient container useful for transporting the collected fluid is the reservoir itself. Alternatively, the collected fluid may be transferred from the reservoir to a transport vial. Finally, the collected fluid can be removed from the transport container via a syringe or other useful transport means.

[0031] The reservoir may be contained in a reservoir component positioned and configured to removably engage the shield.

[0032] In addition to providing oral fluid collection, the reservoir also functions as a liquid / gas separator. As explained in more detail below, the reservoir holds oral fluid collected by the device and separates the oral fluid flow from the air (gas) flow through the device.

[0033] To aid in liquid / gas separation, the reservoir may incorporate a dam to restrict movement of the collected fluid to a second conduit / valve combination described below.

[0034] The material used in making the reservoir is not critical and may include conventional materials such as non-toxic plastic materials. Exemplary plastics include, but are not limited to, polyethylene terephthalate (PET), high density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene (PP), or polyurethane.

[0035] The reservoir may be formed by any useful plastic molding process, including but not limited to injection molding, thermoforming, etc. The reservoir may also be manufactured by standard plastic manufacturing techniques such as injection molding. At least one deformable zone may be composed of an elastomeric material such as rubber, silicone, and soft plastics including but not limited to thermoplastic elastomers or low durometer polyurethanes.

[0036] The first conduit / valve combination allows airflow from the interior of the nipple to an atmospheric vent port disposed on the exterior surface of the device. Depending on the specific details and configuration of the device, the atmospheric vent port may be disposed on the shield or on an optional housing for the reservoir. The location of the one-way valve along the first conduit path is not critical. The one-way valve may be positioned to enhance effective sanitization of the device.

[0037] The second conduit / valve combination allows air flow from the reservoir of the device to the interior of the nipple. Again, the location of the one-way valve along the second conduit path is not critical. The one-way valve may be positioned to enhance effective sanitization of the device.

[0038] The second conduit opening is disposed in the reservoir wall in a location designed to minimize exposure to the collected fluid.

[0039] A third conduit / valve combination allows oral fluids to flow from a collection port located on the outer surface of the nipple (which is disposed in the subject's oral cavity during use) to the reservoir and to an exit port disposed within the reservoir.

[0040] The outlet port may be disposed in a central portion of the interior of the reservoir such that an air gap is provided between the outlet port and the liquid surface of previously collected oral fluid within the reservoir, such that the previously collected oral fluid does not block the flow of new oral fluid releases from the outlet port.

[0041] As will be explained below with reference to the drawings, the outlet port of the third conduit is disposed in a central portion within the reservoir such that an air gap is provided between the outlet port and any previously collected oral fluid.

[0042] Generally, the oral fluid collection devices described above collect and capture oral fluids such as saliva and oral mucosal leakage. While oral gases may also be collected, the fluid conduit / valve elements within the device generally allow a substantial amount of these gases to pass through the system via the atmospheric vent port, while only the oral fluid remains within the reservoir.

[0043] Oral fluid collection devices generally as described above may be manufactured, packaged, and sold as a single disposable device, the packaging protecting the oral fluid collection device from contamination due to damage as the device and / or its components are kept secure during shipping from the manufacturer to the consumer.

[0044] However, a preferred system is a kit of a durable portion and multiple individually packaged reservoir portions, where the durable portion includes the shield and elastomeric nipple (and associated conduit / valve elements), and the individually packaged reservoir portions include the reservoir and optional housing for enclosing the reservoir (and associated conduit / valve elements). Thus, the reservoir portion is removed from its packaging and assembled with the durable portion for use. Alternatively, a single device may be packaged fully assembled with additional separately packaged reservoir portions. After use, the reservoir portions are disassembled from the durable portion, and the collected fluid is then transported for analysis.

[0045] The reservoir portions are arranged and configured for releasable engagement with the durable portion. Thus, a first reservoir portion can be engaged with and detached from the durable portion for collection of a first sample from a subject. The durable portion can be appropriately cleaned and / or disinfected, and the second reservoir portion can be unpackaged and engaged with the durable portion for collection of a second sample from a subject, or even for collection of a second subject. Examples of engagements useful for such releasable engagement include, but are not limited to, screws, pins, bayonets, hooks, and clamps.

[0046] Optionally, the skin-contacting and oral-contacting elements may be disposable, possibly including the elastomeric nipple and shield liner that is positioned toward the lips during use, and possibly also the reservoir and conduit, while the structural shield component and reservoir housing may be reusable (durable), allowing additional components to be incorporated into the durable component.

[0047] Also, refill packages containing multiple packaged reservoir portions and non-durable portions may be provided to the consumer.

[0048] The oral fluid collection kit made available to consumers may also include one or more containers or packaging for sending the reservoir to a testing facility (e.g., a testing laboratory, hospital, clinic, medical testing facility) for analysis. The oral fluid collection kit may also have instructions for transporting the reservoir portion to the testing facility. Thus, the reservoir portion may be sealed and placed in packaging supplied to the consumer as a kit for shipment by mail or delivery service. The supplied packaging may be pre-addressed and insulated to protect the oral collection fluid from extreme temperatures that may affect oral fluid analysis. The supplied return packaging may optionally incorporate a sensor that can be used by the testing laboratory to verify that the reservoir has not been exposed to extreme temperatures.

[0049] Generally, the oral fluid collection device described above is used in a method of collecting oral fluids: Initially, the pressures within the nipple, the reservoir, and the subject's oral cavity or mouth are equal.

[0050] If the oral fluid collection device is disposed within a package, the oral fluid collection device and / or its components are removed (and assembled, if necessary) from the package. Similar to a conventional pacifier, the elastomeric nipple is inserted into the subject's oral cavity. The subject's non-nutritive sucking (NNS) motion on the elastomeric nipple causes deformation (crushing) of the elastomeric nipple. Deforming the elastomeric nipple forces fluid or air from the nipple interior to the atmospheric vent port, where it is expelled to the atmosphere. The fluid follows a path from the nipple interior, into a first fluid conduit and associated first one-way valve, and ultimately exits the oral fluid collection device through an atmospheric vent port disposed on the exterior surface of the device. The first one-way valve prevents air from backfilling the nipple interior from outside the oral fluid collection device via the atmospheric vent port.

[0051] The deformed elastomeric nipple is then allowed to expand to its original shape. In non-nutritive sucking, the infant's tongue moves in a peristaltic motion, alternately applying and then removing load on the elastomeric nipple. As the elastomeric nipple re-expands, the pressure inside the nipple decreases. To re-equilibrate the pressure between the nipple and reservoir interiors, gas must flow from the reservoir interior to the nipple interior. The path the gas follows is from the reservoir interior, into the second fluid conduit and associated second one-way valve, and finally into the nipple interior.

[0052] Because gas has been removed from the interior of the oral fluid collection device, the pressure inside the nipple and reservoir is lower than the pressure inside the subject's mouth. To re-equilibrate the fluid pressure between the interior of the reservoir and the subject's mouth, fluid or air must return to the interior of the reservoir. The fluid source is the subject's mouth. Oral fluid or saliva is drawn from the subject's mouth into the reservoir. The oral fluid follows a path from the mouth, through a collection port located on the outer surface of the nipple, into the third fluid conduit, through the third one-way valve, and finally into the reservoir.

[0053] Again, the reservoir may also have at least one deformable zone that deforms to reduce the volume inside the reservoir. When the at least one deformable zone returns to its resting state, a pressure differential is created between the oral cavity and the interior of the reservoir. As discussed above, fluid flows from the subject's oral cavity into the interior of the reservoir, as discussed above, to re-equilibrate the fluid pressures inside the reservoir and in the subject's oral cavity.

[0054] Additionally, the at least one deformable zone within the reservoir allows for the buildup of a moderate vacuum (negative pressure) within the reservoir; successive suction cycles still move gas out of the elastomeric nipple, particularly when the collection port is blocked by the subject's tongue. The at least one deformable zone deforms more with each cycle, building up mechanical stress within the at least one deformable zone, which in turn can provide increased negative pressure when the collection port is unblocked and the at least one deformable zone returns to its resting state.

[0055] Analysis of oral fluid collected by oral fluid collection devices can be performed at the point of collection, such as with a home test kit, or in many testing laboratories located in hospitals, clinics, and medical testing facilities.

[0056] If the analysis is to be performed in an off-site testing laboratory, the collected fluid must be shipped to the testing site. Thus, the device containing the collected fluid may be shipped in its entirety to the testing site. Alternatively, the reservoir portion may be separated from the durable portion.

[0057] To perform an analysis of the oral fluid, the oral fluid must be removed from the reservoir. The collected fluid may be removed from the reservoir with a syringe, by puncturing a reservoir that has been sealed for shipping, or through an opening in the reservoir created when removing the reservoir portion from the durable portion.

[0058] The subject matter of the present disclosure will now be described more fully hereinafter with reference to the accompanying figures and examples, which are provided to make this disclosure thorough and complete. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter described herein belongs.

[0059] Referring now to the drawings, in which like reference numerals indicate corresponding parts throughout the several views, FIGS. 1-6 are illustrations of an oral fluid collection device of the present invention. FIGS. 1 and 2 are top front and rear perspective views, respectively, of oral fluid collection device 10. FIG. 3 is a side view of device 10. FIGS. 4 and 5 are top front and rear exploded perspective views, respectively, of device 10. Finally, FIG. 6 is a partial cross-sectional side view of oral fluid collection device 10.

[0060] 1, the elastomeric nipple 60 is shown extending from the first surface 22 of the shield 30. FIG. 2 shows the reservoir component 90 extending from the second surface 24 of the first component 20.

[0061] Figure 3, a side view of the oral fluid collection device 10, shows the device 10 having two parts: a first component 20 and a reservoir component 90. Figures 4 and 5 show the first component 20 having three components: a shield 30, a nipple component 50, and a clamp 70. As will be described below, the three components can be assembled to form the first component 20.

[0062] The shield 30 has a first surface 22 and an opposite second surface 32. The shield 30 also has an aperture 34, a vent 36, and an aligner pin 38.

[0063] Nipple component 50 includes an elastomeric nipple 60 and an aligner guide hole 58. Elastomeric nipple 60 includes an outer nipple surface 62 that faces the subject's mouth and an interior nipple surface 66.

[0064] The clamp 70 has a first surface 72, a second surface 24, a second fluid conduit 54, an outlet port 67, a connector 73, an aperture 74, an aligner guide hole 78, a first one-way valve 82, a second one-way valve 84, a third one-way valve 86, and an atmospheric vent port 88. The connector 73 extends from the second surface 24 of the clamp 70 and is shown having the aperture 74 and the outlet port 67. The first one-way valve 82, the second one-way valve 84, and the third one-way valve 86 are disposed on the first surface 72 of the clamp 70. The atmospheric vent port 88 is disposed on the second surface 24 of the clamp 70 and is exposed to the atmosphere. Although the atmospheric vent port 88 is disposed on the second surface 24 of the clamp 70, it may be located on any external surface of the oral fluid collection device 10.

[0065] When the oral fluid collection device 10 is assembled, three fluid conduits are formed. These fluid conduits carry fluid between components and are shown in FIG. 6. When the nipple element 50 and clamp 70 are connected, a first fluid conduit 52 is formed, extending from the nipple interior 66 to the first one-way valve 82. The first fluid conduit 52 and the first one-way valve 82 are operatively connected to allow fluid flow from the nipple interior 66 to the atmospheric vent port 88.

[0066] The second fluid conduit 54 extends from the reservoir interior 98 to the second one-way valve 84. The second fluid conduit 54 and the second one-way valve 84 are operatively connected to allow fluid flow from the reservoir interior 98 to the nipple interior 66.

[0067] The nipple element 50 also has a first portion 56a of a third fluid conduit, while the clamp 70 has a second portion 56b of the third fluid conduit. When the oral fluid collection device 10 is assembled, a third fluid conduit is formed to carry oral fluid from the subject's mouth to the reservoir component 90 of the oral fluid collection device 10.

[0068] The shield 30 and clamp 70 may be constructed from a child-safe material such as plastic.

[0069] Nipple element 50 may be constructed from baby-safe materials such as rubber (natural or latex), silicone, or soft plastic.

[0070] The shield 30, nipple element 50 and clamp 70 may be manufactured by standard plastic manufacturing techniques such as injection molding.

[0071] The first component 20 of the oral fluid collection device 10 is assembled as follows: The nipple element 50 is aligned with the shield 30 such that the elastomeric nipple 60 of the nipple element 50 passes through the aperture 34 of the shield 30 and the aligner pin 38 of the shield 30 passes through the aligner guide hole 58 of the nipple element 50. Here, the elastomeric nipple 60 extends from the first surface 22 of the shield 30 and therefore from the first surface 22 of the first component 20.

[0072] The clamp 70 is aligned with the nipple element 50 so that the aligner guide holes 78 of the clamp 70 are aligned with the aligner pins 38 of the shield 30 .

[0073] The shield 30, nipple element 50, and clamp 70 are held together by a fastener 102. The aligner pin 38 of the shield 30 has internal threads, and the fastener 102 is a threaded fastener. Other types of fasteners include bolts and pins. Alternatively, the three elements of the first component 20 of the oral fluid collection device 10 may be joined together using adhesives, heat sealing, or the like.

[0074] Also shown in the figure is a reservoir component 90 of the oral fluid collection device 10. The reservoir component 90 has a proximal end 91, a distal end 92, side walls 96, and a connector 93 having an aperture 94. The connector 93 extends from the proximal end 91 of the reservoir component 90. A rear cover 95 is disposed at the distal end 92 of the reservoir component 90. The reservoir component 90 also has a reservoir interior 98, which is a void volume in which oral fluids, such as saliva, captured by the oral fluid collection device 10 are stored.

[0075] The reservoir component 90 may also be manufactured by standard plastic manufacturing techniques such as injection molding. The rear cover 95 may be constructed from an elastomeric material such as rubber, silicone, and soft plastic, such that the reservoir component 90 has at least one deformable zone.

[0076] To complete assembly of the oral fluid collection device 10, the first component 20 and the reservoir component 90 are attached so that the reservoir component 90 extends from the second surface 24 of the shield 30. The outward-facing surface of the connector 73 of the clamp 70 is externally threaded, and the inward-facing surface of the aperture 94 on the reservoir component 90 is internally threaded. Thus, the first component 20 and the reservoir component 90 are screwed together into the completed assembly of the oral fluid collection device 10. Alternatively, the outward-facing surface of the connector 73 of the clamp 70 may be internally threaded, and the inward-facing surface of the aperture 94 on the reservoir component 90 may be externally threaded. Alternatively, the first component 20 and the reservoir component 90 are snapped together, or there is a resistance fit or bayonet fit between the connector 73 and the aperture 94.

[0077] 6 is a partial cross-sectional side view of the oral fluid collection device 10. As previously mentioned, the first fluid conduit 52 extends from the nipple interior 66 to the first one-way valve 82. The first fluid conduit 52 and the first one-way valve 82 are operatively connected to allow fluid flow from the nipple interior 66 to the atmospheric vent port 88.

[0078] The second fluid conduit 54 extends from the reservoir interior 98 to the second one-way valve 84. The second fluid conduit 54 and the second one-way valve 84 are operatively connected to allow fluid flow from the reservoir interior 98 to the nipple interior 66.

[0079] A third fluid conduit, including a third fluid conduit first portion 56a and a third fluid conduit second portion 56b, extends from a collection port 64 located on the nipple outer surface 62 through a third one-way valve 86 and a connector 73. The third one-way valve 86 is operably connected to the third fluid conduit first portion 56a and the third fluid conduit second portion 56b to allow fluid to flow from the collection port 64 through the outlet port 67 and into the reservoir interior 98.

[0080] The outlet port 67 is disposed in a central portion of the reservoir interior 98. In FIG. 6, the dotted circle labeled "c" is the linear distance from the proximal end 91, the distal end 92, and the side wall 96 of the reservoir component 90. The dotted circle "c" is defined as 75 percent of the linear distance from any point on the proximal end 91, the distal end 92, and the side wall 96. In this work, the central portion of the reservoir interior 98 is defined as any location within the reservoir interior 98 that is greater than 25 percent of the linear distance from any point on the proximal end 91, the distal end 92, and the side wall 96 of the reservoir component 90 to the circle "c."

[0081] 6, the outlet port 67 is disposed greater than about 75 percent of the linear distance from any point on the proximal end 91 to the circle "c," greater than about 100 percent of the linear distance from any point on the distal end 92 to the circle "c," and greater than about 60 percent of the linear distance from any point on the side wall 96 to the circle "c." Thus, the outlet port 67 is defined as being disposed in a central portion of the reservoir interior 98.

[0082] An advantage of having the outlet port 67 disposed in a central portion of the reservoir interior 98 is that oral fluid collected in the reservoir interior 98 does not block newer fluid from flowing out the outlet port 67.

[0083] Additionally, the connector 73 and its associated aperture 74 protrude into the reservoir interior 98, forming a dam 76. The dam 76 provides a liquid / gas separation barrier to prevent fluid collected in the reservoir interior 98 from contacting the second one-way valve 84 and flowing from the reservoir interior 98 to the nipple interior 66. Oral fluid in the nipple interior 66 can affect the ability of the oral fluid collection device 10 to collect additional oral fluid. The center location of the aperture 74 is in the reservoir interior 98 and also allows the pacifier to operate in most orientations.

[0084] The oral fluid collection device 10 described with reference to the drawings may be used in a method of collecting oral fluid for analysis. This method is generally described above. The following illustrates how the device shown in the drawings may be used in this general method.

[0085] At an initial point, the pressures within the nipple interior 66, the reservoir interior 98, and the subject's (baby's) oral cavity or mouth are equal.

[0086] If the oral fluid collection device 10 is disposed within a package, the consumer first removes the oral fluid collection device 10 from the package. The elastomeric nipple 60 is inserted into the subject's oral cavity. The subject's non-nutritive sucking (NNS) motion on the elastomeric nipple 60 causes the elastomeric nipple 60 to deform (collapse). Deforming the elastomeric nipple 60 forces fluid or air out of the nipple interior 66 and into the atmospheric vent port 88, where it is expelled to the atmosphere. The fluid follows a path from the nipple interior 66 into the first fluid conduit 52, through the first one-way valve 82, and finally through the atmospheric vent port 88 to exit the oral fluid collection device 10. The first one-way valve 82 prevents air from backfilling the nipple interior 66 from outside the oral fluid collection device 10 via the atmospheric vent port 88.

[0087] The deformed elastomeric nipple 60 is then allowed to expand to its original shape. In non-nutritive sucking, the infant's tongue moves in a peristaltic motion, alternately applying and then removing a load on the elastomeric nipple 60. As the elastomeric nipple 60 re-expands, the pressure in the nipple interior 66 decreases. To re-equilibrate the pressure between the nipple interior 66 and the reservoir interior 98, gas must flow from the reservoir interior 98 to the nipple interior 66. The path the gas takes is from the reservoir interior 98 into the second fluid conduit 54, through the second one-way valve 84, and finally into the nipple interior 66.

[0088] Because gas has been removed from the nipple interior 66 and reservoir interior 98 of the oral fluid collection device 10, the internal pressure of the nipple interior 66 and reservoir interior 98 is lower than the pressure within the subject's mouth. Now, fluid or air must return to the reservoir interior 98 to re-equilibrate the fluid pressure between the reservoir interior 98 and the subject's mouth. The source of the fluid is the subject's mouth. Oral fluid or saliva is drawn from the subject's mouth into the reservoir interior 98. The path the oral fluid follows is from the mouth, through the collection port 64 located on the nipple outer surface 62, through the third one-way valve 86, into the third fluid conduit (56a and 56b), and finally into the reservoir interior 98.

[0089] As previously mentioned, reservoir interior 98 is where oral fluids, such as saliva, captured by oral fluid collection device 10 are stored, where the collected fluids can be analyzed to aid in the diagnosis of disease states within the body.

[0090] If the analysis is to be performed in an off-site testing laboratory, the saliva must be shipped to the testing location. After oral fluid collection with the oral fluid collection device 10, the device may be shipped in its entirety to the testing location. Alternatively, after oral fluid collection with the oral fluid collection device 10, the first component 20 and the reservoir component 90 may be first separated by removing the reservoir component 90 from the first component 20. The outward-facing surface of the connector 73 of the clamp 70 is externally threaded, and the inward-facing surface of the aperture 94 on the reservoir component 90 is internally threaded. Thus, the first component 20 and the reservoir component 90 are screwed together into the completed assembly of the oral fluid collection device 10. Unscrewing the first component 20 and the reservoir component 90 is a means of separating the parts of the oral fluid collection device 10.

[0091] To perform an analysis of the oral fluid, the fluid must be withdrawn from the reservoir component 90. In some embodiments, the oral fluid to be tested is withdrawn from the reservoir component 90 of the oral fluid collection device 10 by puncturing the reservoir component 90 using a syringe. Thus, the first component 20 and the reservoir component 90 may be separated by unscrewing them, and a syringe may be used to remove the collected fluid.

[0092] If the reservoir component 90 of the oral fluid collection kit is intended to be sent to a laboratory (hospital, clinic, medical testing facility) for analysis, the reservoir component 90 and the first component 20 are separated when sufficient oral fluid has been collected in the reservoir component 90. The reservoir component 90 may be sealed by disposing a sealing means over the aperture 94. As shown in FIG. 4 , the inner surface of the aperture 94 on the reservoir component 90 is internally threaded. Therefore, a plug with an external external thread may be used to seal the reservoir component 90. The reservoir component 90 may be disposed in a kit supply package for shipping via mail or delivery surface. The supply package may be pre-addressed and insulated to protect the oral fluid collected in the reservoir component 90 from extreme temperatures that may affect oral fluid analysis. [Example]

[0093] An oral fluid collection device 10 was fabricated to test the design. Conventional rapid prototyping techniques were used to form the shield 30, clamp 70, and reservoir component 90. All were fabricated on an Objet Polyjet rapid prototyping machine (Stratasys GmbH, Rheinmunster, DE) using a rigid, opaque Polyjet photopolymer sold under the trade name VeroWhitePlus RGD835 (Stratasys GmbH, Rheinmunster, DE). The elastomeric components (elastomeric nipple 60 shown and rear cover 95 shown) were molded using a prototype mold and a silicone casting resin sold under the trade name DragonSkin™ 30 (Smooth-On, Inc., Macungie, PA). The first one-way valve 82, second one-way valve 84, and third one-way valve 86 were supplied by Minivalve, Inc. (Cleveland, OH). These components were assembled using four standard stainless steel screws. Once assembled, the device was tested for fluid handling capabilities by submerging the collection port 64 in a beaker of water and then applying a continuous compressive force to the elastomeric nipple 60. Continuous compression of the elastomeric nipple 60 resulted in fluid flow and the reservoir component 90 was observed to accumulate fluid.

[0094] The invention described and claimed herein is not limited in scope by the specific embodiments disclosed herein, which are intended to illustrate certain aspects of the invention. Any equivalent embodiments are intended to be within the scope of the invention. Indeed, various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. All publications cited herein are incorporated by reference in their entirety.

[0095] [Embodiment] (1) An oral fluid collection device, comprising: (a) a shield having a first surface and a second surface; (b) an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; (c) a reservoir component extending from the second surface of the shield, the reservoir component comprising a reservoir having a reservoir interior; (d) a first fluid conduit having a first one-way valve operatively connecting and permitting flow from within the nipple to an atmospheric vent port disposed on an exterior surface of the oral fluid collection device; (e) a second fluid conduit having a second one-way valve operatively connecting and allowing flow from the interior of the reservoir to the interior of the nipple; (f) a third fluid conduit having a third one-way valve operably connecting and allowing flow from a collection port disposed on the outer surface of the nipple to an outlet port within the reservoir. (2) An oral fluid collection device as described in embodiment 1, wherein the reservoir component is positioned and configured to removably engage the shield. (3) An oral fluid collection device according to claim 1, wherein the reservoir component further comprises at least one deformable zone. (4) An oral fluid collection device according to claim 1, wherein the reservoir component further comprises a housing for enclosing the reservoir. (5) The oral fluid collection device of embodiment 1, wherein the reservoir component has a buffer solution disposed therein.

[0096] (6) An oral fluid collection device as described in embodiment 1, wherein the outlet port is positioned and configured to provide a gap between the liquid in the outlet port and the liquid inside the reservoir. (7) A method for collecting oral fluids, comprising: (a) removing the oral fluid collection device of embodiment 1 from its packaging; (b) inserting the nipple having an initial rest volume into the oral cavity of a subject; (c) deforming the nipple to force fluid from inside the nipple to the atmospheric vent port; (d) expanding the nipple toward the initial quiescent volume, thereby drawing fluid from within the reservoir and reducing fluid pressure within the reservoir component; (e) drawing oral fluid from the subject's oral cavity into the reservoir through the collection port. (8) The method of embodiment 7, wherein the oral fluid comprises saliva. (9) The method of embodiment 7, further comprising removing the reservoir component from the shield. (10) The method of embodiment 9, further comprising adding a buffer solution to the reservoir.

[0097] (11) The method of embodiment 7, wherein the reservoir component has a buffer solution disposed within the reservoir. (12) The method of any one of claims 10 to 11, further comprising analyzing the oral fluid. (13) An oral fluid collection kit, comprising: (a) a durability component, (i) a shield having a first surface and a second surface; (ii) an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; (b) a plurality of attachable reservoir components arranged and configured to removably engage the shield, each attachable reservoir component comprising a reservoir having a reservoir interior; Assembly of one of the plurality of attachable reservoir components to the durable component defines an oral fluid collection device, the oral fluid collection device having: (1) a first fluid conduit having a first one-way valve operably connecting and allowing flow from an interior of the nipple to an atmospheric vent port disposed on an exterior surface of the oral fluid collection device; (2) a second fluid conduit having a second one-way valve operably connecting and allowing flow from an interior of the reservoir to an interior of the nipple; and (3) a third fluid conduit having a third one-way valve operably connecting and allowing flow from a collection port disposed on the exterior surface of the nipple to an interior of the reservoir. (14) The oral fluid collection kit of embodiment 13, wherein each of the plurality of attachable reservoir components is individually packaged. (15) The oral fluid collection kit of embodiment 13, wherein the reservoir component further comprises at least one deformable zone.

[0098] (16) The oral fluid collection kit of embodiment 13, wherein the reservoir component further comprises a housing for enclosing the reservoir. (17) The oral fluid collection kit of embodiment 13, wherein the reservoir component has a buffer solution disposed therein. (18) The oral fluid collection kit of embodiment 13, wherein the outlet port is disposed in a central portion of the interior of the reservoir. (19) The oral fluid collection kit of embodiment 13, further comprising instructions for transporting the reservoir portion to a testing facility. (20) A method for collecting oral fluid, comprising: (a) removing one of the plurality of attachable reservoir components of embodiment 13 from a package; (b) assembling the oral fluid collection device by attaching the attachable reservoir component of step (a) to the durable component; (c) inserting the nipple having an initial rest volume into the oral cavity of a subject; (d) deforming the nipple to force fluid from inside the nipple to the atmospheric vent port; (e) expanding the nipple toward the initial quiescent volume, thereby drawing fluid from within the reservoir and reducing fluid pressure within the reservoir component; (f) drawing oral fluid from the subject's oral cavity into the reservoir through the collection port.

[0099] 21. The method of claim 20, wherein the oral fluid comprises saliva. (22) The method of embodiment 20, further comprising removing the reservoir component from the shield. 23. The method of claim 22, further comprising adding a buffer solution to the reservoir. (24) The method of embodiment 20, wherein the reservoir component has a buffer solution disposed within the reservoir. 25. The method of claim 23 or 24, further comprising analyzing the oral fluid.

Claims

1. An oral fluid collection device comprising: (a) a shield having a first surface and a second surface; (b) an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; (c) a reservoir component extending from the second surface of the shield, the reservoir component comprising a reservoir having a reservoir interior; (d) a first fluid conduit having a first one-way valve that allows fluid flow from within the nipple to an atmospheric vent port disposed on an exterior surface of the oral fluid collection device; (e) a second fluid conduit having a second one-way valve that allows fluid flow from the interior of the reservoir to the interior of the nipple; (f) a third fluid conduit having a third one-way valve that allows fluid flow from a collection port disposed on the outer surface of the elastomeric nipple to an outlet port within the reservoir.

2. The oral fluid collection device of claim 1 , wherein the reservoir component is positioned and configured to removably engage the shield.

3. The oral fluid collection device of claim 1 , wherein the reservoir component further comprises at least one deformable zone.

4. The oral fluid collection device of claim 1 , wherein the reservoir component further comprises a housing for enclosing the reservoir.

5. The oral fluid collection device of claim 1 , wherein the reservoir component has a buffer solution disposed therein.

6. 10. The oral fluid collection device of claim 1, wherein the outlet port is positioned and configured to provide an air gap between liquid in the outlet port and liquid within the reservoir.

7. 1. An oral fluid collection kit comprising: (a) a durability component, (i) a shield having a first surface and a second surface; (ii) a durable component comprising: an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; (b) a plurality of attachable reservoir components arranged and configured to removably engage the shield, each attachable reservoir component comprising a reservoir having a reservoir interior; Assembly of one of the plurality of attachable reservoir components to the durable component defines an oral fluid collection device, the oral fluid collection device having: (1) a first fluid conduit having a first one-way valve that allows fluid flow from an interior of the nipple to an atmospheric vent port disposed on an exterior surface of the oral fluid collection device; (2) a second fluid conduit having a second one-way valve that allows fluid flow from an interior of the reservoir to an interior of the nipple; and (3) a third fluid conduit having a third one-way valve that allows fluid flow from a collection port disposed on the exterior surface of the elastomeric nipple to an interior of the reservoir.

8. The oral fluid collection kit of claim 7 , wherein each of the plurality of attachable reservoir components is individually packaged.

9. The oral fluid collection kit of claim 7 , wherein the reservoir component further comprises at least one deformable zone.

10. The oral fluid collection kit of claim 7 , wherein the reservoir component further comprises a housing for enclosing the reservoir.

11. 8. The oral fluid collection kit of claim 7, wherein the reservoir component has a buffer solution disposed therein.

12. The third fluid conduit allows fluid to flow from the collection port to an outlet port within the reservoir; 8. The oral fluid collection kit of claim 7, wherein the outlet port is disposed in a central portion of the interior of the reservoir.

13. 8. The oral fluid collection kit of claim 7, further comprising instructions for transporting the reservoir portion to a testing facility.

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